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- Title
123I-mIBG scintigraphy to predict risk for adverse cardiac outcomes in heart failure patients: design of two prospective multicenter international trials.
- Authors
Jacobson AF; Lombard J; Banerjee G; Camici PG; Jacobson, Arnold F; Lombard, John; Banerjee, Gopa; Camici, Paolo G
- Abstract
<bold>Background: </bold>ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) consists of two identical prospective open-label, multicenter, phase 3 studies (MBG311 and MBG312) evaluating the prognostic usefulness of (123)I-mIBG scintigraphy for identifying subjects with heart failure who will experience a major adverse cardiac event.<bold>Methods: </bold>Subjects with NYHA class II and III heart failure and left ventricular ejection fraction < or = 35% were eligible for the trials. Subjects underwent planar and SPECT (123)I-mIBG myocardial imaging, as well as echocardiography and gated SPECT (99m)Tc-tetrofosmin myocardial perfusion imaging. Subjects are then monitored on a regular basis for 2 years. Time to first occurrence of one of the following--NYHA class progression; potentially life-threatening arrhythmic event (including ICD discharge); or cardiac death, as verified by an independent adjudication panel---will be analyzed in comparison to quantitative parameters derived from (123)I-mIBG imaging. The primary efficacy analysis will employ the heart/mediastinum ratio on 4-hour delayed planar imaging, while secondary efficacy analyses will examine quantitative results from both planar and SPECT (123)I-mIBG images, as well as from (99m)Tc-tetrofosmin SPECT and echocardiography.<bold>Conclusion: </bold>The results of the ADMIRE-HF trials will provide prospective validation of the potential role of (123)I-mIBG scintigraphy in assessing prognosis and developing management strategies for patients with heart failure.
- Publication
Journal of Nuclear Cardiology, 2009, Vol 16, Issue 1, p113
- ISSN
1071-3581
- Publication type
journal article
- DOI
10.1007/s12350-008-9008-2